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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Nomograms Used to Define the Short-Term Treatment with PGE1 in Patients with Intermittent Claudication and Critical Ischemia. The ORACL.E (Occlusion Revascularization in the Atherosclerotic Critical Limb) Study Group. The European Study
Angiology, Volume 51, No. 8, Year 2000
Notification
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Description
Infusional, cyclic PGE1 treatment is effective in patients with intermittent claudication and critical limb ischemia (CLI). One of the problems related to chronic PGE1 treatment in vascular diseases due to atherosclerosis is to evaluate the variations of clinical condi tions due to treatment in order to establish the number of cycles per year or per period (in severe vascular disease reevaluation of patients should be more frequent) needed to achieve clinical improvement. In a preliminary pilot study a group of 150 patients (mean age 67 ± 12 years) with intermittent claudication (walking range from 0 to 500 m) and a group of 100 patients with CLI (45% with rest pain, and 55% gangrene; mean age 68 ± 11 years) the number of PGE1 cycles according to the short-term protocol (STP) needed to produce significant clinical improvement was preliminarily evaluated. Considering these preliminary observations, the investigators established a research plan useful to produce nomograms indicating the number of cycles of PGE1-STP per year needed to improve the clinical condition (both in intermittent claudication and CLI). A significant clinical improvement was arbitrarily defined as the increase of at least 35% in walking distance (on treadmill) and/or the disappearance of signs and symptoms of critical ischemia in 6 months of treatment in at least 75% of the treated patients. With consideration of the results obtained with the preliminary nomograms a larger validation of the nomograms is now advisable. A cost-effectiveness analysis is also useful to define the efficacy of treatment on the basis of its costs. The publication of this report in two angiological journals (Angeiologie and Angiology) will open the research on nomograms to all centers willing to collaborate to the study. The data are being collected in the ORACL.E database and will be analyzed within 12 months after the publication of this report. © 2000, Sage Publications. All rights reserved.
Authors & Co-Authors
Belcaro, Giovanni V.
Unknown Affiliation
Nicolaïdes, Andrew N.
Unknown Affiliation
Cazaubon, Michèle
Unknown Affiliation
Errichi, Bruno Maria
Unknown Affiliation
Cornelli, Umberto
Unknown Affiliation
Dugall, Mark
Unknown Affiliation
Corsi, Marcello
Unknown Affiliation
Geroulakos, George
Unknown Affiliation
Fisher, Charles M.
Unknown Affiliation
Szendro, Gabriel
Unknown Affiliation
Simeone, Emilio
Unknown Affiliation
Cesarone, Maria Rosaria
Unknown Affiliation
Bucci, Marco
Unknown Affiliation
Ricci, Andrea
Unknown Affiliation
Ippolito, Edmondo
Unknown Affiliation
Vasdekis, Spyridon N.
Unknown Affiliation
Christopoulos, Dimitrios C.
Unknown Affiliation
Veller, Martin G.
Unknown Affiliation
Venniker, Richard
Unknown Affiliation
Andreozzi, Giuseppe Maria
Unknown Affiliation
Statistics
Citations: 9
Authors: 20
Identifiers
Doi:
10.1177/000331970005100802
ISSN:
00033197